DEVICE: Medline (00888277697198)
Device Identifier (DI) Information
Medline
HCSPUPPYRD
In Commercial Distribution
HCSPUPPYRD
MEDLINE INDUSTRIES, INC.
HCSPUPPYRD
In Commercial Distribution
HCSPUPPYRD
MEDLINE INDUSTRIES, INC.
COMPRESSOR,NEBULIZER, PUPPY, RD
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12716 | Benchtop nebulizer, heated |
An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAF | Nebulizer (direct patient interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091272 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Dry Protect From Freezing, Avoid Excessive Heat |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9b0921dc-22b6-4589-baf1-94a6c51b1688
April 07, 2025
3
October 29, 2021
April 07, 2025
3
October 29, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10888277697195 | 8 | 00888277697198 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-5463
service@medline.com
service@medline.com